An interventional study of Endoscopic surgery and Intensity-modulated radiotherapy in Nasopharyngeal Carcinoma, Endoscopic Surgery and Primary Napharyngeal Carcinama, sponsored by Sun Yat-sen University. Recruiting at 5 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-06-03.
Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Treatment
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Among 186 studies in Nasopharyngeal Carcinoma by Sun Yat-sen University — 80 open to participants now, 107 under way, 43 of them phase 3. Nasopharyngeal Carcinoma · Sun Yat-sen University.
Among the 186 studies in Nasopharyngeal Carcinoma by Sun Yat-sen University, this one is the 62nd largest by planned enrollment of the 161 interventional ones that give a count, is one of 11 that started in 2017, is one of 15 with no phase, reaches primary completion later than 37 of the 106 other live ones, and was the 53rd registered.
683 studies on the registry are indexed under Nasopharyngeal Carcinoma; 270 are open to participants now.
Browse Nasopharyngeal Carcinoma studies →80 of the 186 studies in Nasopharyngeal Carcinoma by Sun Yat-sen University are open now, in 2 countries. Recruiting first, the newest first:
Sun Yat-sen University · Sites in China
Ages 18–70
Sun Yat-sen University · Sites in China
Ages 18–70
Sun Yat-sen University · Sites in China
Ages 2–18
Sun Yat-sen University · Sites in China
Ages 18–70
Sun Yat-sen University · Sites in China
Ages 18–70
By country, each count listing its studies:
Of the 186 Nasopharyngeal Carcinoma studies recruiting now, 42 (23%) set no upper age limit and 135 (73%) stop at 75 or younger; 9 take children under 18; 8 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
186 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 81 · Phase 3 64
First in 1998; this study’s year is marked. 11 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 228 is above the median of 100 across 557 interventional studies indexed under Nasopharyngeal Carcinoma.
Median enrollment 162 across the 161 interventional studies, 470 across the 25 observational. Of the 28 that completed or were terminated, 1 (4%) have results posted.
This tab as a report to print or save as PDF → With an account.
Sun Yat-sen University is the lead sponsor of 1,691 studies on the registry; 619 are open to participants now.
21 of the studies in Nasopharyngeal Carcinoma by Sun Yat-sen University that are under way reach primary completion within a year, 10 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04436965Phase 3Sun Yat-sen UniversityEffect of Standard Nutrition Therapy on Nutritional Status and Prognosis in Locoregionally Advanced Nasopharyngeal Carcinoma Patients With Malnutrition | 2026-12 |
| NCT05340491Phase 3Sun Yat-sen UniversityChemoradiotherapy Plus Anti-PD1 in Recurrent NPC: A Multicenter, Open-label, Randomised, Controlled, Phase III Trial | 2026-12 |
| NCT03907826Phase 3Sun Yat-sen UniversityPD-1 Antibody Combined With Chemoradiotherapy in Recurrent Nasopharyngeal Carcinoma Patients | 2026-12 |
| NCT06241612Phase 3Sun Yat-sen UniversityIndividualized Elective Neck Irradiation in NPC Patients | 2026-12-31 |
| NCT06239727Phase 3Sun Yat-sen UniversityReduced-dose Radiotherapy for Stage III Nasopharyngeal Carcinoma Based on the Treatment Response | 2027-02-20 |
Add all 21 to your calendar (.ics) → With an account.
Among the 186 studies in Nasopharyngeal Carcinoma by Sun Yat-sen University, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Nasopharyngeal carcinoma (NPC) is most prevalent in eastern Asia, with the highest incidence reported among the Cantonese population from the province of Guangdong. Radiotherapy is the cornerstone of initial treatment due to the radiosensitive behavior of NPC and its deep-seated location. Although radiotherapy has achieved satisfactory results, it can also cause some severe adverse events. Currently, surgery is only applied to the treatment of recurrent NPC (rNPC) patients, mainly dominated by the conventional open surgery. However, the traditional surgery was accompanied by high rate of treatment-induced complications and low rate of block removal, which greatly limited the surgical application to the treatment of primary NPC.
With the continuous improvement in surgical techniques, especially the electronic endoscopic system to be used in the surgical treatment recently, endoscopic nasopharyngectomy can largely overcome these shortcomings of traditional surgery mentioned above.
In addition, the investigators retrospectively analyzed the survival outcomes of 9 patients with NPC (all T1N0M0 according to the UICC / AJCC seventh staging) treated with endoscopic nasopharyngectomy in our hospital, with 5-year rate of overall survival, loco-regional-free survival, distant metastasis-free survival of 100%. Therefore, the investigators considered endoscopic nasopharyngectomy for staged I NPC patients feasible.
This study will focus on the survival outcomes and quality of life of the staged I NPC patients treated with endoscopic nasopharyngectomy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stage I patients were only treated with endoscopic surgery without additional chemotherapy. Endoscopic nasopharyngectomy included endoscopic resection , with or without posterior pedicle nasal mucoperiosteal flap resurfacing the nasopharyngeal defects.
Procedure: Endoscopic surgery
Stage I patients were only treated with radical intensity-modulated radiotherapy without additional chemotherapy. IMRT was delivered with a dynamic multileaf intensity-modulating collimator (NOMOS, Sewickley, PA) by a slice-by-slice arc rotation approach.
Radiation: Intensity-modulated radiotherapy
Endoscopic nasopharyngectomy included endoscopic resection, with or without posterior pedicle nasal mucoperiosteal flap resurfacing the nasopharyngeal defects.
All of the patients were received irradiation by IMRT. The target volumes were delineated according to a previously described institutional treatment protocol, which is in accordance with the International Commission on Radiation Units and Measurements reports 50 and 62.
overall survival
The event for overall survival (OS) was death from any cause. The duration was calculated from the date of treatment initiation to the date of death or last follow-up.
Time frame: 3 years
distant metastasis-free survival
The event for distant metastasis-free survival (DMFS) was distant metastasis. The duration was calculated from the date of treatment initiation to the date of distant metastasis or the last follow-up.
Time frame: 3 years
loco-regional relapse-free survival
The event for loco-regional relapse-free survival (LRRFS) was loco-regional recurrence. The duration was calculated from the date of treatment initiation to the date of loco-regional relapse or last follow-up.
Time frame: 3 years
the rates of complications
These complications included mucositis, pharyngitis, xerostomia, nasopharyngeal necrosis
Time frame: 1 year
Started Oct 2017 (actual). Primary completion is estimated for Oct 2025, 96 months after the start.
Of 49 interventional studies with no phase under Nasopharyngeal Carcinoma, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 22. This study's planned 96 months is above that.
How these figures are worked out, and which studies are left out of them.
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